PregnancyPhase 3DHANI-2NCT03072277
Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2)
A Phase 3 study testing Docosa Hexaenoic Acid (DHA) in people with Pregnancy, run by Public Health Foundation of India at 1 site in India.
Trial summary
DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Docosa Hexaenoic Acid (DHA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 957 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
- 18-35 years
- Hb > 7 g/dL
- Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (<140mg/dL)
- No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
- High risk pregnancy (short stature**, molar pregnancy++, HBsAg positive, as advised by physicians)
- <143 cm ++ A molar pregnancy starts when an egg is fertilized, but instead of a normal, viable pregnancy resulting, the placenta develops into an abnormal mass of cysts.
Who cannot join
- Women allergic (if aware) to any of the test products.
- Women at high risk for hemorrhagic bleeding, clotting (if aware).
- Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
- Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
- Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).
Trial locations and contacts
1 site in 1 country.
India1 site
KLEUs Jawaharlal Nehru Medical College -- Prabhakar Kore Charitable Hospital
Belagavi, Karnataka, 590010
About this study
Official title: Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)
DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.
Read the detailed description
A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).
- Conditions
- Pregnancy
- Being tested
- Docosa Hexaenoic Acid (DHA), Placebo
- Keywords
- DHA, Docosa Hexaenoic Acid, Omega 3 fatty acid, Birth Outcome, Birth Size, Gestational Age, DASII, Prenatal and Postnatal Supplementation, Randomized Controlled Trial, Neurodevelopment, Pregnancy, Lactation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosa Hexaenoic Acid (DHA)Dietary supplement
Also called Omega 3 Fatty Acid
400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through 6 months postpartum.
PlaceboDietary supplement
Also called Corn/Soy oil
400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Docosa Hexaenoic Acid (DHA) | Active comparator | Omega 3 Fatty Acid Receives: Dietary Supplement: Docosa Hexaenoic Acid (DHA) |
| Placebo | Placebo comparator | Corn/Soy Oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age
The development quotient (DQ) among infants at 12 months of age assessed using the standardized Development Assessment Scale for Indian Infants (DASII). DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD). Median reliability index for motor and mental scales based on correlation between consecutive months is noted to be 0.88 for motor scales and 0.91 for mental scales.
Measured: 12 months (± 4 weeks)
Secondary outcomes (15)
Mean difference in infant developmental quotient (DQ) at 6 month
Mean Difference in the infant developmental quotient (DQ) as measured by the Development Assessment Scale for Indian Infants (DASII) at 6 months. DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD).
Measured: 6 months (± 4 weeks)
Mean difference in infant motor score at 6 month
Mean Difference in the motor score as measured by the Development Assessment Scale for Indian Infants (DASII) at 6 months. DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. A higher score indicates a better outcome. The motor development items cover the child's development from supine to erect posture, neck-control, locomotion etc. It also includes the record for manipulative behaviour such as reaching, picking-up, handling things etc.
Measured: 6 (± 4 weeks)
Mean difference in infant mental score at 6 month
Mean Difference in the mental score as measured by the Development Assessment Scale for Indian Infants (DASII) at 6 months. DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. A higher score indicates a better outcome. The mental development items record the child's cognizance of objects in the surroundings, perceptual pursuit of moving objects, exploring them to meaningful manipulation. It also covers the development of communication and language comprehension, spatial relationship and manual dexterity, imitative behavior and social interaction etc.
Measured: 6 months (± 4 weeks)
Difference in numbers / proportions of infants with developmental delay
Difference in numbers / proportions of infants with developmental delay between the Docosa-hexaenoic acid (DHA) and placebo group at 6 and 12 months. Developmental delay will be defined as a Development Quotient score ≤70 as assessed by Development Assessment Scale for Indian Infants (DASII).
Measured: 6 months (± 4 weeks) and 12 (± 4 weeks) months
Mean difference in infant weight (in grams) at birth
Mean difference in infant weight score between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth weight is measured to the nearest 10 g by using a digital pediatric scale. Low birth weight is defined as recorded birth weight less than 2500 g.
Measured: At delivery
Mean difference in infant (in centimeters) at birth
Mean difference in infant length between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth length is the height of infant from maximum convexity of head to heel of the foot of the baby just after birth. It is measured using a portable infantometer with a fixed headpiece according to standard procedures. The Body length at birth is recorded in centimetres (cm) to 1 decimal place.
Measured: At delivery
Mean difference in infant head circumference (in centimeters) at birth
Mean difference in infant head circumference between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth length is the measurement of a child's head around its largest area - the distance from above the eyebrows and ears and around the back of the head. It is measured using non-stretchable measuring tape. It should be written in cm to 1 decimal place.
Measured: At delivery
Mean difference in infant APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score at birth.
Mean difference in APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score between the Docosahexaenoic acid (DHA) and placebo group at birth. The APGAR score is a way to quickly measure and simply the health of an infant immediately after birth by adding the scores of the five criteria- Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability/ response), Activity (muscle tone) and Respiration to come up with a single number. This test is done at 1, 5 minutes. A low score on the 1-minute test may show that the neonate requires medical attention but is not necessarily an indication that there will be long-term problem.
Measured: At delivery
Mean change in infant weight (in grams) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Mean change in infant weight at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group. Birth weight is measured to the nearest 10 g by using a digital pediatric scale. Low birth weight is defined as recorded birth weight less than 2500 g.
Measured: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean change in infant length (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Mean change in infant length Docosahexaenoic acid (DHA) and placebo group at birth, 1 month, 6 months and 12 months between the DHA and placebo group. Birth length is the height of infant from maximum convexity of head to heel of the foot of the baby just after birth. It is measured using a portable infantometer with a fixed headpiece according to standard procedures. The Body length at birth is recorded in centimetres (cm) to 1 decimal place.
Measured: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean change in infant head circumference (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Mean change in infant size head circumference Docosahexaenoic acid (DHA) and placebo group at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group. Mean difference in infant head circumference between the Docosahexaenoic acid (DHA) and placebo group at birth. Birth length is the measurement of a child's head around its largest area - the distance from above the eyebrows and ears and around the back of the head. It is measured using non-stretchable measuring tape. It should be written in cm to 1 decimal place.
Measured: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups.
Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups. Stillbirths are defined as fetuses delivered at 20 weeks of gestation or later with no signs of life and recorded as occurring before or during the onset of labor.
Measured: At delivery
Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups.
Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups. Preterm delivery is defined as delivery after 20 weeks and before 37 weeks of completed gestation. Foetal losses during pregnancy - including miscarriages/abortions and still-births are recorded by study personnel on site or details are brought by field workers (in case mother went to any other hospital).
Measured: At delivery
Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups.
Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups. Low birth weight is defined as recorded birth weight less than 2500 g.
Measured: At delivery
Difference in infant morbidity patterns between Docosahexaenoic acid (DHA) and placebo groups
Difference in infant morbidity patterns (types of illness, frequency and duration of specific conditions) between DHA and placebo group. Information collected on infant morbidity include questions reporting of illnesses - cough, nasal congestion, difficulty in breathing, cyanosis, convulsions, fever, vomiting, rash, ear discharge, excessive crying, and diarrhoea from birth till the age of 12 months
Measured: 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startDec 2015
- Primary completionApr 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blinded, parallel arm hospital based trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of India
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College, India Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072277
- Sponsor's protocol ID
- IA/CPHE/14/1/501498
- Acronym
- DHANI-2
- Status last verified
- Mar 2021
- First submitted
- 23 Feb 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khandelwal S, Swamy MK, Patil K, Kondal D, Chaudhry M, Gupta R, Divan G, Kamate M, Ramakrishnan L, Bellad MB, Gan A, Kodkany BS, Martorell R, Srinath Reddy K, Prabhakaran D, Ramakrishnan U, Tandon N, Stein AD. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol. BMC Pediatr. 2018 Aug 4;18(1):261. doi: 10.1186/s12887-018-1225-5.
PubMed 30077178Khandelwal S, Kondal D, Chaudhry M, Patil K, Swamy MK, Metgud D, Jogalekar S, Kamate M, Divan G, Gupta R, Prabhakaran D, Tandon N, Ramakrishnan U, Stein AD. Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial. Nutrients. 2020 Oct 3;12(10):3041. doi: 10.3390/nu12103041.
PubMed 33023067Khandelwal S, Kondal D, Chaudhry M, Patil K, Swamy MK, Pujeri G, Mane SB, Kudachi Y, Gupta R, Ramakrishnan U, Stein AD, Prabhakaran D, Tandon N. Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANI. Nutrients. 2021 Feb 25;13(3):730. doi: 10.3390/nu13030730.
PubMed 33668849
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)
- ClinicalTrials.gov ID
- NCT03072277
- Acronym / sponsor ID
- DHANI-2 / IA/CPHE/14/1/501498
- Conditions
- Pregnancy
- Keywords
- DHA, Docosa Hexaenoic Acid, Omega 3 fatty acid, Birth Outcome, Birth Size, Gestational Age, DASII, Prenatal and Postnatal Supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 957 participants (actual)
- Lead sponsor
- Public Health Foundation of IndiaUniversity, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College, India Alliance
- Study start
- Dec 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.
Detailed description
A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blinded, parallel arm hospital based trial.
| Arm | Type | Receives |
|---|---|---|
| Docosa Hexaenoic Acid (DHA) | Active comparator | Dietary Supplement: Docosa Hexaenoic Acid (DHA)Omega 3 Fatty Acid |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCorn/Soy Oil |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
- 18-35 years
- Hb > 7 g/dL
- Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (<140mg/dL)
- No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
Key exclusion criteria (5 listed)
- Women allergic (if aware) to any of the test products.
- Women at high risk for hemorrhagic bleeding, clotting (if aware).
- Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
- Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
- Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosa Hexaenoic Acid (DHA)Also: Omega 3 Fatty Acid400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through 6 months postpartum. | Dietary supplement | Docosa Hexaenoic Acid (DHA) |
| PlaceboAlso: Corn/Soy oil400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum. | Dietary supplement | Placebo |
Primary outcome
Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age
Time frame: 12 months (± 4 weeks)
The development quotient (DQ) among infants at 12 months of age assessed using the standardized Development Assessment Scale for Indian Infants (DASII). DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD). Median reliability index for motor and mental scales based on correlation between consecutive months is noted to be 0.88 for motor scales and 0.91 for mental scales.
15 secondary outcomes
Mean difference in infant developmental quotient (DQ) at 6 month
Time frame: 6 months (± 4 weeks)
Mean difference in infant motor score at 6 month
Time frame: 6 (± 4 weeks)
Mean difference in infant mental score at 6 month
Time frame: 6 months (± 4 weeks)
Difference in numbers / proportions of infants with developmental delay
Time frame: 6 months (± 4 weeks) and 12 (± 4 weeks) months
Mean difference in infant weight (in grams) at birth
Time frame: At delivery
Mean difference in infant (in centimeters) at birth
Time frame: At delivery
Mean difference in infant head circumference (in centimeters) at birth
Time frame: At delivery
Mean difference in infant APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score at birth.
Time frame: At delivery
Mean change in infant weight (in grams) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Time frame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean change in infant length (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Time frame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean change in infant head circumference (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
Time frame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups.
Time frame: At delivery
Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups.
Time frame: At delivery
Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups.
Time frame: At delivery
Difference in infant morbidity patterns between Docosahexaenoic acid (DHA) and placebo groups
Time frame: 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 30077178Khandelwal S, Swamy MK, Patil K, Kondal D, Chaudhry M, Gupta R, Divan G, Kamate M, Ramakrishnan L, Bellad MB, Gan A, Kodkany BS, Martorell R, Srinath Reddy K, Prabhakaran D, Ramakrishnan U, Tandon N, Stein AD. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol. BMC Pediatr. 2018 Aug 4;18(1):261. doi: 10.1186/s12887-018-1225-5.
- Results publication: PubMed 33023067Khandelwal S, Kondal D, Chaudhry M, Patil K, Swamy MK, Metgud D, Jogalekar S, Kamate M, Divan G, Gupta R, Prabhakaran D, Tandon N, Ramakrishnan U, Stein AD. Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial. Nutrients. 2020 Oct 3;12(10):3041. doi: 10.3390/nu12103041.
- Results publication: PubMed 33668849Khandelwal S, Kondal D, Chaudhry M, Patil K, Swamy MK, Pujeri G, Mane SB, Kudachi Y, Gupta R, Ramakrishnan U, Stein AD, Prabhakaran D, Tandon N. Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANI. Nutrients. 2021 Feb 25;13(3):730. doi: 10.3390/nu13030730.
- The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocolLink provided by the sponsor.
- Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled TrialLink provided by the sponsor.
- Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANILink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docosa Hexaenoic Acid (DHA) in people with Pregnancy, run by Public Health Foundation of India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age (time frame: 12 months (± 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072277, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.