Iron Deficiency AnemiaNCT06957717
Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls
A study testing cow's milk kefir and pasteurized cow's milk in people with Iron Deficiency Anemia, run by Lusyana Gloria Doloksaribu at 1 site in Indonesia.
Trial summary
Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- cow's milk kefir and pasteurized cow's milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent girls aged 15-18 years
- Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
- Have a normal menstrual cycle and duration
Who cannot join
- Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
- Taking supplements other than TTD
- Taking antibiotics in the last 3 months
- Suffering from lactose intolerance through interviews
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Gadjah Mada University
Yogyakarta, Special Region of Yogyakarta, 55281
Lusyana Gloria Doloksaribu, Doctoral student, 085360637111, lusyanagloriadoloksaribu@mail.ugm.ac.id
Susetyowati, Promotor, 0818277781, susetyowati@ugm.ac.id
About this study
Official title: Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls in Yogyakarta, Indonesia
Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment
Read the detailed description
This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.
- Conditions
- Iron Deficiency Anemia
- Being tested
- cow's milk kefir, pasteurized cow's milk
- Keywords
- Kefir, Short Chain Fatty Acid, Hemoglobin, Ferritin, Iron Deficiency Anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cow's milk kefirCombination product
Also called intervention group
group given cow's milk kefir and blood supplement tablets (TTD)
pasteurized cow's milkCombination product
Also called control group
group given pasteurized cow's milk and blood supplement tablets (TTD)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Fresh cow's milk drink pasteurized at 72 °C, and fermented by kefir grain (5%) for 24 hours at 25 °C, then filtered to produce cow's milk kefir, and stored at 4 °C for 24 hours before drinking, given as 1 bottle/day of 120 ml + 10% liquid sugar for 2 months. Receives: Combination Product: cow's milk kefir |
| control group | Placebo comparator | Fresh cow's milk drink pasteurized at 72 °C, without fermentation, given 1 bottle/day of 132 ml for 2 months Receives: Combination Product: pasteurized cow's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Chain Fatty Acid
SCFA (acetate, propionate, and butyrate) levels in fresh feces of adolescent girls, using the GC-MS (Gas Chromatography-Mass Spectrometry) Method, were measured before (0 months) and after the intervention (2 months), using a ratio scale.
The examination procedure included collecting feces in the field according to the procedure at https://drive.google.com/drive/folders/1uXklwFuC-1rnQ1Anim86b7-9pqLSheIz. Fresh feces samples were collected immediately, by storing them in a cool box (to maintain the quality of feces so that it remains stable during storage and transportation, and avoid the maturation process that can affect the results of lab tests, so that the results of the lab analysis carried out can be accurate and valid), and then immediately taken to the laboratory to quantify each of the short chain fatty acids (SCFA) in the sample.
Measured: 2 months after intervention
hemoglobin
Adolescent girls' hemoglobin values in the blood taken from the median cubital vein, using the hematology analyzer method (unit g/dl), were measured before (0 months) and after the intervention (2 months), using a ratio scale.
Measured: 2 months after intervention
Ferritin
Ferritin content in the blood of adolescent girls taken from the median cubital vein, using the Ferritin ELISA method (unit µg/L), was measured before (0 months) and after the intervention (2 months), using a ratio scale
Measured: 2 months after intervention
Secondary outcomes (4)
Nutrient intake
The amount of nutrients iron, folic acid, protein, vitamin C, zinc, energy and fat that enter the body of adolescent girls per day obtained from food and beverages, using the Food Record method carried out for 3 days, consisting of 2 times weekday and 1 time weekend, analyzed using the Nutrisurvey 2007 application, measured before (0 months) and after the intervention (2 months), using a ratio scale.
Measured: 2 months after intervention
Nutritional status of adolescent girls (body mass index / age)
The Z-score or standard deviation (SD) value of adolescent girls after calculating the ratio of body weight in kilograms (kg) squared with height in meters (m) correlated with age, was analyzed using the WHO AnthroPlus application, measured before (0 months) and after the intervention (2 months), using a ratio scale.
Weight values were obtained by weighing adolescent girls using digital scales with an accuracy of 0.1 kg. Height values were obtained by measuring the height of adolescent girls using a microtoise with an accuracy of 0.1 cm, and age was obtained by asking about the date/month/year of birth of adolescent girls. Using a questionnaire.
Measured: 2 months after intervention
Menstrual cycle and duration of adolescent girls
The physiological process experienced by adolescent girls, namely periodic bleeding from the uterus accompanied by the release of the endometrial wall every month, was obtained through a questionnaire, using an ordinal scale, with the categories (1). Normal if the menstrual cycle ranges from 21-35 days, and the length of menstruation is 3-7 days, and (2). Abnormal if the menstrual cycle ranges <21 days and >35 days, and the duration of menstruation is <3 days and >7 days
Measured: 2 months after intervention
Diarrhea
Complaints of watery or loose bowel movements that occur more than 3 times a day were obtained through a questionnaire, using an ordinal scale, with the categories (1). No diarrhea if the frequency of bowel movements ranged from 1-2 times/day, with a solid consistency, and (2). Diarrhea, the frequency of bowel movements ranging ≥3 times/day, watery, thin consistency
Measured: 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Its research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta, as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lusyana Gloria Doloksaribu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lusyana Gloria Doloksaribu, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957717
- Sponsor's protocol ID
- GadjahMada
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data will be shared, but in the form of coding.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls in Yogyakarta, Indonesia
- ClinicalTrials.gov ID
- NCT06957717
- Acronym / sponsor ID
- GadjahMada
- Conditions
- Iron Deficiency Anemia
- Keywords
- Kefir, Short Chain Fatty Acid, Hemoglobin, Ferritin, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lusyana Gloria DoloksaribuUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 4 May 2025 (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.
Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment
Detailed description
This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Its research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta, as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Combination Product: cow's milk kefirFresh cow's milk drink pasteurized at 72 °C, and fermented by kefir grain (5%) for 24 hours at 25 °C, then filtered to produce cow's milk kefir, and stored at 4 °C for 24 hours before drinking, given as 1 bottle/day of 120 ml + 10% liquid sugar for 2 months. |
| control group | Placebo comparator | Combination Product: pasteurized cow's milkFresh cow's milk drink pasteurized at 72 °C, without fermentation, given 1 bottle/day of 132 ml for 2 months |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescent girls aged 15-18 years
- Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
- Have a normal menstrual cycle and duration
Key exclusion criteria (4 listed)
- Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
- Taking supplements other than TTD
- Taking antibiotics in the last 3 months
- Suffering from lactose intolerance through interviews
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 |
|---|---|---|
| cow's milk kefirAlso: intervention groupgroup given cow's milk kefir and blood supplement tablets (TTD) | Combination product | intervention group |
| pasteurized cow's milkAlso: control groupgroup given pasteurized cow's milk and blood supplement tablets (TTD) | Combination product | control group |
Primary outcome
Short Chain Fatty Acid
Time frame: 2 months after intervention
SCFA (acetate, propionate, and butyrate) levels in fresh feces of adolescent girls, using the GC-MS (Gas Chromatography-Mass Spectrometry) Method, were measured before (0 months) and after the intervention (2 months), using a ratio scale. The examination procedure included collecting feces in the field according to the procedure at https://drive.google.com/drive/folders/1uXklwFuC-1rnQ1Anim86b7-9pqLSheIz. Fresh feces samples were collected immediately, by storing them in a cool box (to maintain the quality of feces so that it remains stable during storage and transportation, and avoid the maturation process that can affect the results of lab tests, so that the results of the lab analysis carried out can be accurate and valid), and then immediately taken to the laboratory to quantify each of the short chain fatty acids (SCFA) in the sample.
hemoglobin
Time frame: 2 months after intervention
Adolescent girls' hemoglobin values in the blood taken from the median cubital vein, using the hematology analyzer method (unit g/dl), were measured before (0 months) and after the intervention (2 months), using a ratio scale.
Ferritin
Time frame: 2 months after intervention
Ferritin content in the blood of adolescent girls taken from the median cubital vein, using the Ferritin ELISA method (unit µg/L), was measured before (0 months) and after the intervention (2 months), using a ratio scale
4 secondary outcomes
Nutrient intake
Time frame: 2 months after intervention
Nutritional status of adolescent girls (body mass index / age)
Time frame: 2 months after intervention
Menstrual cycle and duration of adolescent girls
Time frame: 2 months after intervention
Diarrhea
Time frame: 2 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Yes. IPD data will be shared, but in the form of coding.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cow's milk kefir and pasteurized cow's milk in people with Iron Deficiency Anemia, run by Lusyana Gloria Doloksaribu at 1 site in Indonesia.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 May 2025. 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 Indonesia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lusyana Gloria Doloksaribu (085360637111, lusyanagloriadoloksaribu@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Chain Fatty Acid (time frame: 2 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2025.