The effect of micronutrient supplementation in combination with healthy lifestyle coaching on nutrition status and well-being: A 6-month study in Ghana
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202402872415588
- Lead Sponsor
- Innonext
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 150
?Apparently healthy students in their second and third-years of study
?Female and male aged 18 - 25 years
?Agree to remain in the study area for the 26-week period of the follow-up
?Gives written informed consent
?Individuals taking routine micronutrient supplements
?History of food allergies and sensitivity to micronutrient supplement consumption
?Sensitivities to any compositions of the micronutrients
?Pregnant students as per their last menstrual period
?Taking medications that could interact with the micronutrient supplements. Key medications which deplete the absorption of micronutrients include acid-suppressing and antacids, antiepileptic drugs (anti-convulsants), antibiotics, hormone replacement therapy (estrogens), digoxin, anti-inflammatory/analgesics (Karadima et al, 2016)
?Cases of severe anaemia (hemoglobin less than 7 g/dl)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total serum 25-hydroxyvitamin D (25(OH)D) Vitamin D will be the primary biomarker endpoint. It is the major circulating form of vitamin D in the blood. At endline, we expect to see a clinically significant increase in the baseline serum 25(OH)D among the intervention groups <br><br>
- Secondary Outcome Measures
Name Time Method <br>A secondary outcomes that will be obtained through interviews are targeted at assessing the psychological wellbeing of the participants. The change from baseline to endline will include the levels of severity of depression, anxiety and stress and the subjective well being of the participants measured using the DASS-21 (Depression Anxiety Stress Scale) and the CSSW (College Student Subjective Wellbeing) questionnaires, respectively.<br><br>